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ISO 13485 & EU MDR - Expert Advice Community



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  • Filling documents

    1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?

    2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?

  • Distributor and ISO 13485

    I am revising the Distributor's Agreement and wondering to what extent our quality control shall go to ensure the ISO 13485?
    In other words, how much can I ask of the distributor in terms of complying with ISO 13485? 
    Should the medical device distributor have ISO certification or only knowledge of it?

  • Internal auditor selection

    We come across this clause in the Internal Audit procedure: 

    [Job title] selects auditors in such a way as to ensure objectivity and impartiality, i.e. to avoid conflict of interest, because auditors are not allowed to audit their own work.

    Given that our company is quite small, all employees are doing work relating to the ISO and therefore, an internal auditor may encounter something in the audit relating to their own work. Furthermore, the candidates that are able to assess all sides of the procedures (including the R&D technical side) are limited.

    Does this mean that we have to hire an external auditor?

  • MDR classification

    Best MDR classification of a non-invasive, low power (8mW pulsed at 10% duty cycle) near infrared sensor applied to skin (hand web) in a transitory fashion for use over extended periods of time?

  • Drug-device combination product development and manufacturing

    My main question is what is the regulation or what level of ISO 13485 should be compliance for Drug-device combination product development and manufacturing, ie the pen-injector or auto-injector for insulin or other drug? 

  • Risk Management Question

    We've been filling the risk management table on the 06th document but we have a question: ¿which processes should we include? Because we have many processes such as R&D, operations, production, QA, sales, delivery etc. but we wonder which ones should we include?

  • How long and how much for emdr 2a certification of software ai as medical device?

    How long and how much for emdr 2a certification of software ai as medical device?

  • Validation of equipment

    Hi, I was wondering if it is a requirement according to ISO 13485:2016 to use validated equipment during manufacturing and QC of IVDs

  • Distributors role in UK MDR changes


    Would anyone have any upto date information documents on the role of distributors in UK MDD/ MDR.  With the changes of the MHRA now extending the deadline also, some of my customers and sub distributors are asking me questions that I don't have answers to, becasue as far as I was aware I can't see any changes that imapct distributors.



  • Questions on Training Procedure and Procedure for Infrastructure and Work Environment

    1. The reason of my mail is to ask you on which document of the toolkit can I find the one that describes the trainings product?

    2. On the Procedure for Infrastructure and Work Enviroment document, on section 3.5 (Monitoring and measuring environmental conditios) I wonder if this section is necessary environmental conditions nor a cleanroom to do the device, the device is not invasive and it's mostly a software with sensors to check basic vital signs using IoT. Thank you very much for your help and I'll be
    waiting for your answers.

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